MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134702

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary was completed on july 31, 2020.The device was visually inspected and the distal tip was misshaped and had a sharp edge.A second closer inspection was performed and it was found that electrode #02 was misshaped and lifted.Then, an electrical test was performed and the catheter failed.No electrical readings were observed on electrode #02 due to misshaped and lifted.Then, magnetic sensor functionality was tested on the carto and the catheter was properly visualized and no errors were observed.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The customer complaint was confirmed.The root cause of the misshaped and lifted electrode #02 cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.This issue was highly detectable by the physician.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the biosense webster, inc.Product analysis observed the returned condition of a lifted electrode with a sharp edge.Initially it was reported that a current leakage error 7, then a 401 error, map points could not be acquired, displayed on the carto 3 system.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure continued.There was no patient consequence reported.Additional information was received on the event.The current leakage error 7 was displayed due to a signal loss issue.All signals were lost on the body surface and intracardiac channels on both the carto 3 system and the recording system.However, there were signals available for the physician to monitor the patient¿s heart rhythm under the defibrillator and the anesthesia monitor.The signal loss issue was assessed as not mdr reportable.The patient¿s heart rhythm was still visible to the operator.The risk to the patient was low.The current leakage error was assessed as not mdr reportable.The issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.The mapping issue was assessed as not mdr reportable.Since the catheter cannot map by the carto 3 system, the user will not be able to use the device and will have to replace it.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.(bwi) product analysis (pa) received the device for evaluation and on july 14, 2020 they observed that the distal tip was misshaped and had a sharp edge.In addition, the device was further examined on july 28, 2020 and it was found that electrode #02 was misshaped and lifted.Per request, additional clarification was received on july 28, 2020 on the returned condition.The bwi representative reported that they could not confirm whether the damage was inflicted during or post procedure.The returned condition of the lifted electrode with the sharp edge was assessed as mdr reportable.The awareness date for this issue is july 14, 2020.

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10394579
• MDR Text Key: 202588094
• Report Number: 2029046-2020-01033
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2020
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30248409M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNKNOWN BRAND CABLE; UNKNOWN BRAND RECORDING SYSTEM